Where Mammograms Fail

At the recent TEDwomen conference in Washington D.C., one of the presenters was Dr. Deborah Rhodes, an internist who has become a leader in assessing breast cancer risk. Rhodes became immersed in the challenge of how to effectively detect breast tumors in women with dense breast tissue when one of her pregnant patients, in her 40s and with a family history of breast cancer, asked her for an honest appraisal of the odds of finding a tumor in its early stages.

Rhodes understood that for women with dense breast tissue, “the mammogram doesn’t work well at all.” In fact, as she wrote to me via e-mail,

Breast tissue density poses a higher risk for breast cancer than having a mother or sister with the disease, but 9 out of 10 women don’t know this—or how dense their breast tissue is.

Breast density is genetically determined. Rhodes qualifies it as the “culprit” for inadequate readings of mammograms. She explained that two-thirds of women in their 40s have dense breast tissue. Although breast density usually declines as a woman ages, up to one-third of women retain breast density for years after they reach menopause.

How important is it for women to know about their breast density? Very. You can learn this information from your mammogram report. Rhodes showed slides that illustrated the four categories of breast density. There are two groups who are at greater risk for not having a tumor detected: those in the heterogeneously dense group (51-75 percent density) and those in the extremely dense group (over 75 percent density). Both tumors and dense breast tissue appear as white on mammograms. For those with fatty breasts there is an 80 percent probability of finding a cancer, as opposed to the 40 percent likelihood of finding a cancer in a dense breast.

There has been little change in the field of mammography since the 1960s other than the development of digital mammography—which is still an x-ray of the breast. Ultrasound is used, as are MRIs—which are costly.

The a-ha moment for Rhodes came when she was introduced to Michael O’Connor, a nuclear physicist. He told her about gamma technology. Gamma rays are not affected by breast density. Rhodes and O’Connor, along with a core hub of two radiologists and a bio-medical engineer, have formed the Molecular Breast Imagery (MBI) Research Team at Mayo Clinic. They are currently working on a “dual-head” gamma camera that can detect tiny tumors in dense breast tissue.

With chances for a cure dropping off as the size of a tumor increases, finding a tumor at one centimeter gives a patient a 90 percent chance for successful treatment. The work that Rhodes and her group are doing got them a major nod in 2004, when they received a grant from the Susan G. Komen Breast Cancer Foundation: They were funded to study 1,000 women with dense breast tissue, and compare the results with mammography. With mammography, 25 percent of cancers were detected; with MBI, the result was 83 percent. A combination of the two yielded a 92 percent detection rate. Rhodes showed an example of how a 67-year old woman who had received a clean bill of health with a digital mammogram was found to have a 3.7-centimeter tumor with an MBI.

Getting their findings published in the January 2011 issue of the Journal of Radiology has helped them gain traction and exposure in the larger medical community. Now they need to finalize the screening studies using the low dose. Protocol demands that the study has to be “replicated” at other institutions. That could take five or more years.

Although the MBI unit has been FDA approved, it is still not widely available. Rhodes referenced “economic and political forces,” in addition to the science, as contributing factors.

While this technology is continuing to be advanced, Rhodes recommended the following guidelines to women:

* Know your breast density (only the state of Connecticut has mandated that women receive notification of their breast density after taking a mammogram).

* If you are pre-menopausal, try to schedule your mammogram during the first two weeks of your menstrual cycle, when breast density is relatively lower.

* If you notice a persistent change in your breast, insist on having additional imagery screening.

* Women 40 and older with dense breasts should have a mammogram every year

A strong believer in women’s self-empowerment through self-knowledge about their breast density, Rhodes wrote to me,

I think it is important for women to understand the limitations of a test that they are having year after year–so we can collectively advocate for developing [such] an alternative.

Excerpted from MarciaGYerman.com; you can read the full article here. This article originally appeared on the women’s health site Empowher.

Comments

Years ago I had a breast cancer scare when I found a little lump under my arm. The doctor told me it was probably a swollen gland but sent me for a mammogram anyway. The tech told me I had dense breast tissue that would make the mammogram difficult to read, and that this was usually the case for younger women. The mammogram apparently was not sufficient so I was sent for a sonogram (the guy there creeped me out so bad I swore I would never go back). That was also inconclusive and I had a biopsy. the Dr who reviewed the biopsy said it was nothing bus cysts and that the whole thing was a waste of time. My Dr. simply told me I should get annual mammograms from now on. I had to ask a lot of questions at each step to even get the minimal information I got, and the general answer of "well, you have no risk factors but should get annual mammograms" left me feeling anxious and dissatisfied. I have never had another. I am now over 40 and my current doctor is talking to me about annual mammograms. When I tell him about the dense tissue he shrugs and says it is generally recommended. I think I will print this out and take it to my next appointment (hopefully not until next year) when he is guaranteed to bring it up again.

There's something new that's been tested in Southern California at the Huntington-Hill Imaging center, associated with The Huntington Hospital in Pasadena, for dense breast readings. It's called SonoCine, an enhanced sonographic method, which was developed by radiologist, Kevin M. Kelly, MD. It is now being offered at The Hall Health & Longevity Center in Venice, CA, by Dr. Kelly and there are other sources that offer it, but I don't know where those are. My radiation oncologist, Ruth Williamson, MD, Medical Director of Huntington Hospital's Constance G. Zahorik Breast Cancer center, has referred me to Dr. Kelly to have a sonocine annually, alternately, in a six month interval, with an annual regular mammogram (she told me there is valuable information that can't be seen any other way) taken along with a regular sonogram. I share in case anyone wishes to look into this. It seems to me to be a very complete screening program. My best wishes to all who may need it!

We at the Institute for Health Quality and Ethics have recently filed a Citizen’s Petition with the FDA to correct the practice of withholding of material medical information from patients and providing false and misleading mammogram results to women with dense breast tissue. The FDA has continued to violate the requirements of the Mammogram Quality Standards Act through its failure to adequately implement and enforce the patient notification statute. The Petition requests that the FDA immediately correct the practice of sending false and misleading information to as many as 16 million patients per year, and that complete and accurate information about breast density be provided to the 40 million women per year who obtain mammograms.

Of the 40 million women who receive mammograms each year, nearly 16 million have mammograms that are unreadable or inconclusive at best. As Dr. Rhodes mentions in her discussion, these women have dense tissue which is difficult for a mammogram to distinguish from cancer. Rather than inform these women that their mammograms are difficult to read with any degree of certainty, the FDA permits facilities to send a patient notification letter indicating that the mammogram is normal if no cancer is detected.

Years of peer reviewed studies have confirmed that for women with dense breast tissue, a film mammogram may detect as few as 27% of cancers, and a digital mammogram may miss more than 40% of cancers. Providing patients a “normal” result for this low degree of certainty is clearly false and misleading, and is a serious violation of the public trust. Because material information about breast density is withheld from the 40 million women a year who obtain mammograms, women are denied their right to make informed decisions about their own health, a violation of all medical ethical standards in the United States and a violation of the federal patient notification statute of the MQSA. Women with dense breast tissue also have an increased risk for cancer of 4-6 times, one of the highest risk factors after having a close family member with the disease.

False negative mammogram reports are not tracked in the United States, which has enabled the breast cancer screening industry to maximize mammography throughput at the expense of the best interests of patients. We have worked with others in the industry, reviewed the studies conducted both within the US as well as across Europe and Canada, and have extrapolated from the available figures. We estimate that up to 10,000 women per year may eventually die as a result of their reliance on these false mammogram results. These deaths are almost entirely preventable with readily available supplemental or alternative screening.